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510(k) Data Aggregation
(139 days)
The OXY-1 System is intended to be used for extracorporeal circulation. The OXY-1 System pumps, oxygenates and removes carbon dioxide from blood during cardiopulmonary bypass up to 6 hours in duration.
The Abiomed OXY-1 System provides extracorporeal circulation for cardiopulmonary bypass support for up to six hours in duration. The OXY-1 System includes:
- A Disposable pump and oxygenator .
- A Pump Driver (blood pump) ●
- Blood tubing .
- A Console for controlling the pump and managing gas flow .
These components are designed to operate together, simplify operation, and reduce the overall equipment footprint at the bedside.
The provided text is a 510(k) summary for the Abiomed OXY-1 System, a cardiopulmonary bypass oxygenator. It is not a document describing an AI/ML-driven medical device, nor does it contain information about acceptance criteria or studies related to AI/ML device performance.
Therefore, I cannot extract the requested information regarding acceptance criteria and the study proving the device meets them, specifically in the context of an AI/ML device, as the provided document pertains to a traditional medical device (a cardiopulmonary bypass oxygenator).
The information requested in your prompt (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are all relevant to the validation of AI/ML models. Since this document describes a physical medical device, these concepts are not applicable.
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(280 days)
The OXY-1 System is intended to be used for extracorporeal circulation. The OXY-1 System pumps, oxygenates and removes carbon dioxide from blood during cardiopulmonary bypass up to 6 hours in duration.
The Breethe® OXY-1 System provides extracorporeal circulation for full or partial cardiopulmonary bypass support for up to six hours. The OXY-1 System includes; a disposable pump and oxygenator, a pump driver, blood tubing, and a console for powering and controlling the pump and managing gas flow. These components are designed to operate together to reduce the overall equipment footprint at the bedside.
The provided text is a 510(k) Summary for the Abiomed OXY-1 System, a cardiopulmonary bypass oxygenator. It outlines the device's characteristics, comparison to predicates, and performance data submitted to the FDA for substantial equivalence determination.
However, the document does not contain information related to a study involving acceptance criteria for an AI/ML medical device, human reader performance, ground truth establishment by experts, or MRMC studies. The performance data mentioned (Biocompatibility, Electrical Safety, Software V&V, and Performance Testing per FDA guidance) relates to the physical and functional aspects of the OXY-1 System hardware and software, typical for a Class II medical device of this type, not an AI/ML diagnostic or prognostic system.
Therefore, I cannot extract the information required by your request from the provided text, as the request is geared towards an AI/ML device study, which is not described herein.
To fulfill your request, I would need a document detailing the clinical validation or performance study of an AI/ML medical device.
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